The present invention relates to a sealing device for a percutaneous puncture, in particular to an applicator device to seal a percutaneous puncture in a body or blood vessel of a patient.
Various intravascular and intralumenal surgical operations are routinely performed on a patient through catheterization by opening a puncture in the patient. Typical operations are cardiac output measurements with Swanguns catheter by thermal dilution method; cardiac, neurological, and vascular angiography; percutaneous transluminal coronary angioplasty(PTCA); and peripheral transluminal angioplasty(PTA). In all of those operations, a patient's arterial vessel is punctured by a needle, and various types of guide wires and catheters are inserted into the vessel through a puncture. After the procedure, the catheter is withdrawn and the puncture site is mechanically clamped or pressurized for several hours, typically up to 12 hours to prevent bleeding. Under these operations, most patients are heparinized, i.e. coagulation of blood is lessened, so that bleeding does not stop easily.
One method being attempted to shorten the bleeding is to insert a pellet of collagen into the puncture site through a sheath. In this method, firstly, the depth of the artery from the skin is measured by a needle when the puncture is made by the needle. Then, a device with a predetermined length, which is formed of a sheath and a dilator or a rounded stick slidably situated in the sheath, is selected. Thereafter, the device is inserted in the puncture. Now, the dilator is removed from the sheath, and collagen pellet is inserted into the sheath and is pushed forwardly inside the sheath by a plunger. Once the plunger goes all the way to the forward end of the sheath, the plunger is held and the sheath is taken out slowly. Collagen stays in the puncture site. If necessary, another pellet may be further applied to fully fill out the puncture.
Collagen is a fibrous material, and once blood is absorbed by collagen, the collagen starts to activate platelets to form coagulum. Thus, the puncture is blocked and bleeding is effectively stopped.
In the applicator as stated above, the whole system is formed of the sheath, the plunder, one or more collagen pellet, and a dilator. Also, there are many steps to perform and the process is very complicated. Namely, the collagen pellets must be pushed by the plunger and the sheath must be withdrawn slowly. Moreover, it is very difficult to control the depth of collagen being placed, because the placement of the collagen pellets is very critical, i.e. collagen should not go into the artery.
Accordingly, one object of the invention is to provide a simplified applicator device to apply a strip of hemostatic material directly in the percutaneous puncture site to prevent bleeding without using a complicated devices.
Another object of the invention is to provide an applicator device as stated above, wherein the applicator device can be inserted into the puncture site and release hemostatic material at the exact depth without learning a special skill.
Further objects and advantages of the invention will be apparent from the following description of the invention.